At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 119 enrolled
Drug / intervention
Guselkumab +1 moredrug
Likely dose
Guselkumab 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicenter, Randomized, Open-Label, Efficacy Assessor-Blinded, Active Comparator-Controlled Phase 3b Study to Compare the Efficacy of Guselkumab to Fumaric Acid Esters (Fumaderm Initial/ Fumaderm) for Adult Patients With Moderate to Severe Plaque Psoriasis Who Are Candidates for and Naive to Systemic Treatment
In Brief
A Phase 3 clinical trial evaluating Guselkumab and Fumaric Acid Esters for Psoriasis. Completed, enrolled 119 participants across 28 sites.
Detailed Summary
The purpose of the study is to compare the efficacy of Guselkumab with commercially available active comparator Fumaderm initial/Fumaderm tablets for the treatment of adult participants with moderate to severe plaque-type psoriasis who have not yet received any systemic therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
CountriesGermany
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 2016
Enrollment StartDec 2016
Primary CompletionSep 2017
Study CompletionFeb 2019
TodayJul 2026
First PostedNov 1, 2016
Enrollment StartDec 12, 2016
Primary CompletionSep 13, 2017
Study CompletionFeb 6, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.7 years ago
Interventions
Guselkumabdrug
Participants will receive 100 mg of Guselkumab as 100 mg/mL solution subcutaneously.
Fumaric Acid Estersdrug
Participants will receive Fumaderm initial/ Fumaderm tablets through self-administration.